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FDA Chief McClellan Testifies on Drug Importation Concerns

He said the agency would examine whether the practice could be legalized without jeopardizing patient safety.

The White House’s pick to head Medicare agreed to address the Senate Commerce Committee after Sen. Byron Dorgan, D-N.D., vowed to block a Senate floor vote on McClellan’s nomination until he answered questions before the committee.

In another response to the mounting pressure from drug importation supporters, the Bush administration decided not to go ahead with McClellan’s appointment to lead a government study of importing drugs from Canada. Some on Capitol Hill had complained McClellan’s outspoken opposition to drug imports meant he could not be an impartial leader.

Dorgan’s spokesman Barry Piatt told the Online NewsHour that after Thursday’s testimony the senator was still weighing whether to continue his hold on McClellan’s nomination. Piatt said it was not enough for McClellan to simply sit before the committee and that, given his reluctance to answer the senators’ questions, Dorgan had to decide whether to allow the nomination to move forward.

Committee Chairman John McCain, R-Ariz., opened Thursday’s hearing by saying, “Opponents of importation must come to the table with ideas for how to build an effective importation system that protects both the health and the pocketbooks of American consumers.”

During his testimony McClellan said that the FDA is not “opposed to undertaking a thorough effort to determine whether and how importation could be accomplished safely. But this cannot be accomplished by fiat or with a presumption of safety.”

Throughout his testimony, he emphasized the difficulty of insuring imported drugs would be safe. Citing recent “blitz” examinations of packages containing imported drugs, he cautioned that those “shipments often contain dangerous or unapproved drugs that pose potentially serious safety problems.”

The Senate must confirm McClellan before he can assume the post of administrator of the Centers for Medicare and Medicaid Services, the agency that runs the government health insurance programs for nearly 80 million poor, elderly and disabled Americans.

On Wednesday, the White House warned that senators holding up McClellan’s confirmation were delaying implementation of a $530 billion Medicare bill that provides prescription drug benefits for seniors.

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